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临床试验/NCT01670188
NCT01670188终止不适用

Sequential Pneumatic Compression to Prevent PICC-related Upper Extremity Venous Thrombosis in Critically Ill Neurological Patients

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2012年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
Mayo Clinic
入组人数
78
试验地点
2
主要终点
Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis

研究概览

简要总结

The purpose of this study is to see if a compression device on the arm where a peripherally inserted central catheter (PICC) line has been inserted can prevent the formation of a blood clot around the PICC line.

详细描述

In a pilot prospective randomized controlled trial, consecutive patients requiring placement of a PICC line in the Neuroscience intensive care unit were randomly assigned to either the SCD (intervention) group or a non SCD (control) group.

Standardized vascular access patency protocols was used in all enrolled patients. All patients had an indwelling 5 French, double lumen PICC unless additional venous access was required by the primary service. Patients randomized to the intervention arm had an SCD placed in the arm with the PICC within 24 hours of PICC placement.

Five to seven days after placement of the PICC, the patients were examined with venous duplex ultrasound of the upper extremity to assess for the presence of venous thrombosis. The patients also had the ultrasound again 12-14 days post insertion if the PICC was kept for more than 10 days. If the PICC line was removed before 5-7 days, an upper extremity ultrasound was obtained upon PICC removal. In case of suspected symptomatic venous thromboembolism, the investigations were performed according to current practice standards. Data collection was be considered complete upon removal of the PICC line.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject's age is greater than or equal to 18 years
  • Subject is patient in neuro intensive care unit at time of PICC placement

排除标准

  • Acute trauma to the upper extremity harboring the PICC
  • Current use of prophylactic anticoagulation
  • Inability to fit the SCD on the arm because of arm size
  • Documented previous upper extremity DVT in the arm harboring the PICC line

研究组 & 干预措施

Pneumatic SCD

Active Comparator

Use of pneumatic SCD (VenaFlow System - DJO Global) on upper extremity with PICC line inserted.

干预措施: Pneumatic SCD - VenaFlow System (DJO Global) (Device)

Non-SCD group

No Intervention

Standard care

结局指标

主要结局

Number of Patients Who Experienced an Ultrasonographically-confirmed Venous Thrombosis

时间窗: baseline to 14 days post insertion of PICC line

Ultrasonographically-confirmed upper extremity venous thrombosis (symptomatic and asymptomatic) in arm with PICC catheter

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alejandro Rabinstein

PI

Mayo Clinic

研究点 (2)

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